HypertensionNCT06917131
Royal Jelly as a Strategy to Modulate Inflammation and Oxidative Stress in Patients With Systemic Arterial Hypertension
A study testing Royal Jelly in people with Hypertension and Cardiovascular Diseases (CVD), run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
The study aims to evaluate the effect of the royal jelly on inflammation and oxidative stress in participants with systemic arterial hypertension. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants for two months. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Cardiovascular Diseases (CVD), Inflammation
- What is being tested?
- Royal Jelly
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Sep 2024to 10 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stage 1 hypertension
- Regular treatment for more than 6 months
- No changes in medication doses during the last 3 months
Who cannot join
- Autoimmune diseases
- Infectious diseases
- Diabetes
- Chronic kidney disease
- Liver disease
- Cancer
Show all 14Show fewer
- AIDS
- Pregnant women
- Use of catabolic drugs or antibiotics
- Use of antioxidant vitamin supplements, prebiotics, probiotics, or synbiotics
- Habitual intake of royal jelly
- Allergy to bee stings
- Acute myocardial infarction (AMI)
- Stroke (CVA)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Denise Mafra
Rio de Janeiro, Rio de Janeiro, 22260050
Ludmila Cardozo, PhD, +5521987333185, ludmila.cardozo@gmail.com
About this study
The study aims to evaluate the effect of the royal jelly on inflammation and oxidative stress in participants with systemic arterial hypertension. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants for two months.
Read the detailed description
Royal jelly (RG) is considered a superfood that has been used in traditional medicine and dietary supplementation due to its antioxidant, anti-inflammatory, immunomodulatory, and regenerative properties. The antioxidant and anti-inflammatory effects of GR highlight its potential as a natural supplement for the prevention and management of several health conditions. Although in vitro and animal model data are promising, clinical studies are still needed to validate the effects of royal jelly in human populations.
- Conditions
- Hypertension, Cardiovascular Diseases (CVD), Inflammation
- Being tested
- Royal Jelly, Placebo
- Keywords
- royal jelly, inflammation, Hypertension, cardiovascular diseases
- Medical subject headings
- Hypertension, Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Royal JellyDietary supplement
Participants will receive 2 capsules per day, providing the dosage of 300mg of royal jelly for 2 months (8 weeks).
PlaceboDietary supplement
The placebo group will receive 2 capsules per day (containing microcrystalline cellulose and magnesium stearate in colored gelatin capsules capable of masking the appearance of the internal content), at the same time for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Royal Jelly Group | Experimental | Participants will receive 2 capsules per day, providing the dosage of 300mg of royal jelly for 2 months (8 weeks). Receives: Dietary Supplement: Royal Jelly |
| Placebo Group | Placebo comparator | The placebo group will receive 2 capsules per day (containing microcrystalline cellulose and magnesium stearate in colored gelatin capsules capable of masking the appearance of the internal content), at the same time for 2 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of inflammatory transcripton factor
Assessment of NFkB expression levels in blood samples collected at baseline and after 8 weeks of supplementation.
Measured: Baseline and 8 weeks
Secondary outcomes (5)
Change in interleukin-6 (IL-6) levels
Assessment of changes in serum interleukin-6 (IL-6) levels after supplementation.
Measured: Baseline and 8 weeks
Change in tumor necrosis factor-alpha (TNF-α) levels
Assessment of changes in serum tumor necrosis factor-alpha (TNF-α) levels after supplementation.
Measured: Baseline and 8 weeks
Change in Nrf2 expression
Assessment of changes in Nrf2 expression after supplementation.
Measured: Baseline and 8 weeks
Change in C-reactive protein (CRP) levels
Assessment of changes in serum C-reactive protein (CRP) levels after supplementation.
Measured: Baseline and 8 weeks
Change in antioxidant enzyme activity
Assessment of changes in antioxidant enzyme activity after supplementation.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start18 Sep 2024
- Primary completion10 Dec 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ludmila Cardozo, PhD, Principal investigator, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917131
- Sponsor's protocol ID
- Denise Mafra21
- Status last verified
- May 2026
- First submitted
- 1 Apr 2025
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be public to other research unless necessary.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Royal Jelly as a Strategy to Modulate Inflammation and Oxidative Stress in Patients With Systemic Arterial Hypertension
- ClinicalTrials.gov ID
- NCT06917131
- Acronym / sponsor ID
- Denise Mafra21
- Conditions
- Hypertension, Cardiovascular Diseases (CVD), Inflammation
- Keywords
- royal jelly, inflammation, Hypertension, cardiovascular diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate the effect of the royal jelly on inflammation and oxidative stress in participants with systemic arterial hypertension. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants for two months.
Detailed description
Royal jelly (RG) is considered a superfood that has been used in traditional medicine and dietary supplementation due to its antioxidant, anti-inflammatory, immunomodulatory, and regenerative properties. The antioxidant and anti-inflammatory effects of GR highlight its potential as a natural supplement for the prevention and management of several health conditions. Although in vitro and animal model data are promising, clinical studies are still needed to validate the effects of royal jelly in human populations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Royal Jelly Group | Experimental | Dietary Supplement: Royal JellyParticipants will receive 2 capsules per day, providing the dosage of 300mg of royal jelly for 2 months (8 weeks). |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboThe placebo group will receive 2 capsules per day (containing microcrystalline cellulose and magnesium stearate in colored gelatin capsules capable of masking the appearance of the internal content), at the same time for 2 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of stage 1 hypertension
- Regular treatment for more than 6 months
- No changes in medication doses during the last 3 months
Key exclusion criteria (14 listed)
- Autoimmune diseases
- Infectious diseases
- Diabetes
- Chronic kidney disease
- Liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Royal JellyParticipants will receive 2 capsules per day, providing the dosage of 300mg of royal jelly for 2 months (8 weeks). | Dietary supplement | Royal Jelly Group |
| PlaceboThe placebo group will receive 2 capsules per day (containing microcrystalline cellulose and magnesium stearate in colored gelatin capsules capable of masking the appearance of the internal content), at the same time for 2 months. | Dietary supplement | Placebo Group |
Primary outcome
Change of inflammatory transcripton factor
Time frame: Baseline and 8 weeks
Assessment of NFkB expression levels in blood samples collected at baseline and after 8 weeks of supplementation.
5 secondary outcomes
Change in interleukin-6 (IL-6) levels
Time frame: Baseline and 8 weeks
Change in tumor necrosis factor-alpha (TNF-α) levels
Time frame: Baseline and 8 weeks
Change in Nrf2 expression
Time frame: Baseline and 8 weeks
Change in C-reactive protein (CRP) levels
Time frame: Baseline and 8 weeks
Change in antioxidant enzyme activity
Time frame: Baseline and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No. Participant data will not be public to other research unless necessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ludmila Cardozo, PhD principal investigator
Universidade Federal Fluminense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Royal Jelly in people with Hypertension and Cardiovascular Diseases (CVD), run by Universidade Federal Fluminense at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denise mafra, PhD (+5521985683003, dmafra30@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of inflammatory transcripton factor (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.